Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes

Type 1 Diabetes Mellitus Clinical Trial

— DEPICT 2  

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Dapagliflozin as an Add-on to Insulin Therapy in Subjects With Type 1 Diabetes Mellitus - Study Two

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02460978
• Other study ID #: MB102-230
• Secondary ID: 2014-004599-49D1
• Status: Completed
• Phase: Phase 3
• Start date: July 8, 2015
• Est. completion date: April 18, 2018

Study information

• Verified date: February 2019
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and effective therapy to improve glycemic control in patients with type 1 diabetes.

Description:

Study Classification: Safety, Efficacy and Pharmacokinetics/dynamics

Recruitment information / eligibility

• Status: Completed
• Enrollment: 815
• Est. completion date: April 18, 2018
• Est. primary completion date: September 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Type 1 Diabetes mellitus (T1DM)

• Central laboratory C-peptide < 0.7 ng/ml (0.23 nmol/L)

• Insulin use for at least 12 months per patient reported or medical records

• Method of insulin administration (MDI or CSII) must have been unchanged for at least 3 months prior to screening

• Subjects must be on a total insulin dose of = 0.3 U/kg/day for at least 3 months prior to screening

• If on MDI insulin administration, subject must be on = 3x injections per day

• Screening Visit: Central laboratory HbA1c = 7.7% and = 11.0%

• Body mass index (BMI) = 18.5 kg/m2

Exclusion Criteria:

• History of Type 2 Diabetes mellitus (T2DM) or maturity onset diabetes of the young (MODY), pancreatic surgery, or chronic pancreatitis that could result in decreased beta cell capacity

• Taking any non-insulin antihyperglicemic agent within 1 month prior to screening

• Taking GLP-1 receptor agonist within 2 months prior to screening for once weekly administration and within 1 month prior to screening for once or twice daily administration

• Taking metformin and/or thiazolidinediones within 2 months prior to screening

• History of diabetes ketoacidosis requiring medical intervention within 1 month prior to screening

• History of hospital admission for glycemic control (either hyperglycemia or hypoglycemia) within 1 month prior to screening

• Frequent episodes of severe hypoglycemia (more than one episode requiring medical assistance, emergency care), and/or glucagon therapy administered by a third-party individual within 1 month prior to screening

• History of Addison's disease

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• Dapagliflozin
Tablets

Other:
• Placebo for dapagliflozin
Tablets

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Caba
Argentina	Research Site	Cordoba
Argentina	Research Site	Cordoba
Argentina	Research Site	Corrientes
Argentina	Research Site	Mar del Plata
Argentina	Research Site	Ramos Mejía
Belgium	Research Site	Brussels (Uccle)
Belgium	Research Site	Leuven
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Cambridge	Ontario
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Sherbrooke	Quebec
Canada	Research Site	Smiths Falls	Ontario
Chile	Research Site	Santiago
Chile	Research Site	Santiago
Chile	Research Site	Temuco
Germany	Research Site	Dresden
Germany	Research Site	Essen
Germany	Research Site	Falkensee
Germany	Research Site	Freiburg im Breisgau
Germany	Research Site	Hamburg
Germany	Research Site	Heidelberg
Germany	Research Site	Oldenburg
Germany	Research Site	Pohlheim
Germany	Research Site	Saarlouis
Germany	Research Site	Sulzbach-Rosenberg
Germany	Research Site	Wangen
Japan	Research Site	Aki-gun
Japan	Research Site	Amagasaki-shi
Japan	Research Site	Chitose-shi
Japan	Research Site	Chuo-ku
Japan	Research Site	Fukuyama-shi
Japan	Research Site	Higashiosaka-shi
Japan	Research Site	Ibusuki-shi
Japan	Research Site	Kagoshima-shi
Japan	Research Site	Kamakura-shi
Japan	Research Site	Kashiwara-shi
Japan	Research Site	Kitakyushu-shi
Japan	Research Site	Koriyama-shi
Japan	Research Site	Kumamoto-shi
Japan	Research Site	Kurume-shi
Japan	Research Site	Miura-shi
Japan	Research Site	Nagoya-shi
Japan	Research Site	Obihiro-shi
Japan	Research Site	Oita-shi
Japan	Research Site	Osaka-shi
Japan	Research Site	Oyama-shi
Japan	Research Site	Sapporo-shi
Japan	Research Site	Shibuya-ku
Japan	Research Site	Shinjuku-ku
Japan	Research Site	Shizuoka-shi
Japan	Research Site	Tsukuba-shi
Japan	Research Site	Ushiku-shi
Japan	Research Site	Uwajima-shi
Japan	Research Site	Yokohama-shi
Japan	Research Site	Yokohama-shi
Netherlands	Research Site	Hoogeveen
Netherlands	Research Site	Maastricht
Netherlands	Research Site	Utrecht
Poland	Research Site	Bialystok
Poland	Research Site	Bialystok
Poland	Research Site	Gdansk
Poland	Research Site	Krakow
Poland	Research Site	Kraków
Poland	Research Site	Kraków
Poland	Research Site	Lublin
Poland	Research Site	Warsaw
Poland	Research Site	Wroclaw
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	St. Petersburg
Russian Federation	Research Site	St.Petersburg
Sweden	Research Site	Göteborg
Sweden	Research Site	Helsingborg
Sweden	Research Site	Linkoping
Sweden	Research Site	Uddevalla
Switzerland	Research Site	Olten
Switzerland	Research Site	St. Gallen
Switzerland	Research Site	Zollikerberg
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Northampton
United Kingdom	Research Site	Oldham
United Kingdom	Research Site	Swansea
United Kingdom	Research Site	Wakefield
United States	Research Site	Albany	New York
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Amarillo	Texas
United States	Research Site	Atlanta	Georgia
United States	Research Site	Atlanta	Georgia
United States	Research Site	Austin	Texas
United States	Research Site	Bennington	Vermont
United States	Research Site	Bradenton	Florida
United States	Research Site	Chicago	Illinois
United States	Research Site	Chicago	Illinois
United States	Research Site	Clearwater	Florida
United States	Research Site	Concord	California
United States	Research Site	Dallas	Texas
United States	Research Site	Des Moines	Iowa
United States	Research Site	Edina	Minnesota
United States	Research Site	Edinburg	Texas
United States	Research Site	Federal Way	Washington
United States	Research Site	Flushing	New York
United States	Research Site	Fort Lauderdale	Florida
United States	Research Site	Fresno	California
United States	Research Site	Golden	Colorado
United States	Research Site	Jacksonville	Florida
United States	Research Site	Jefferson City	Missouri
United States	Research Site	Kalamazoo	Michigan
United States	Research Site	Lexington	Kentucky
United States	Research Site	Lexington	Kentucky
United States	Research Site	Los Angeles	California
United States	Research Site	Mesquite	Texas
United States	Research Site	Miami	Florida
United States	Research Site	Miami Springs	Florida
United States	Research Site	Mineola	New York
United States	Research Site	New Hyde Park	New York
United States	Research Site	New York	New York
United States	Research Site	Newark	Delaware
United States	Research Site	Orange	California
United States	Research Site	Overland Park	Kansas
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Reno	Nevada
United States	Research Site	Roswell	Georgia
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Saint Petersburg	Florida
United States	Research Site	San Antonio	Texas
United States	Research Site	San Antonio	Texas
United States	Research Site	San Mateo	California
United States	Research Site	San Ramon	California
United States	Research Site	Tampa	Florida
United States	Research Site	Walnut Creek	California

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Canada,  Chile,  Germany,  Japan,  Netherlands,  Poland,  Russian Federation,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adjusted Mean Change From Baseline in HbA1c at Week 24	To compare the change from baseline in HbA1c between dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment	Baseline and 24 weeks
Secondary	Adjusted Mean Percentage Change From Baseline in Total Daily Insulin Dose at Week 24	To compare the percent change from baseline in total daily insulin dose with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment	Baseline and 24 weeks
Secondary	Adjusted Mean Percentage Change From Baseline in Body Weight at Week 24	To compare the percentage change from baseline in body weight with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment	Baseline and 24 weeks
Secondary	Adjusted Mean Change From Baseline in 24-hour Continuous Glucose Monitoring (CGM) Mean Value at Week 24	To compare the change from baseline in mean value of 24-hour glucose readings obtained from CGM with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment	Baseline and 24 weeks
Secondary	Adjusted Mean Change From Baseline in 24-hour CGM Mean Amplitude of Glycemic Excursion (MAGE) Value at Week 24	To compare the change from baseline in mean amplitude of glucose excursions (MAGE) of 24-hour glucose readings obtained from CGM with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment	Baseline and 24 weeks
Secondary	Change From Baseline in the Percent of 24-hour Glucose Readings Obtained From CGM That Falls Within the Target Range of > 70 mg/dL and <= 180 mg/dL (%) at Week 24	To compare the change from baseline in the percent of 24-hour glucose readings obtained from CGM that falls within the target range of >70 mg/dL and <=180 mg/dL with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment	Baseline and 24 weeks
Secondary	Percentage of Subjects With HbA1c Reduction From Baseline to Week 24 Last Observation Carried Forward (LOCF) >= 0.5% and Without Severe Hypoglycemia Events at Week 24	To compare dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin for the proportion of subjects achieving an HbA1c reduction from baseline to Week 24 visit >=0.5% without severe hypoglycemia events	Baseline and 24 weeks

External Links

•   MB102230_CSP
•   MB102230_SAP